Randomized Clinical Trial of the Effect of Standard Versus Intensive Intervention Protocol in Attempting to Reduce Recurrent Episodes of Acute Alcoholic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The number of recurrent pancreatitis during the study period
研究概览
简要总结
Retrospective studies have shown, that about half of the patients will have a recurrent episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than half annually are treated for recurrent acute pancreatitis. Because alcohol has been shown an important factor in the development of recurrent pancreatitis, it was hypothesized, that by attempting intensively to diminish the individual alcohol consumption the number of recurrent pancreatitis could be decreased. Two protocols will be compared: A) initial intervention against alcohol abuse and B) repeated interventions at 6 month intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who recovered from their first acute alcoholic pancreatitis and start to be ready to be discharged from hospital
排除标准
- •Other etiologies of pancreatitis besides alcohol
- •Uncertain diagnosis
- •Recurrent disease
研究组 & 干预措施
1
All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. In addition, they also will undergo repeated similar interventions at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period.
干预措施: Repeated behavioural intervention without any drugs (Behavioral)
Standard
All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period.
结局指标
主要结局
The number of recurrent pancreatitis during the study period
时间窗: 2 years
次要结局
- Decrease of alcohol consumption(2 years)